Articles

Reconstructing the Legal Framework for Drug and Food Supervision by Indonesia's Food and Drug Supervisory Agency: A Conceptual and Practical Analysis

    Authors

  • Farina Firda Eprilia Faculty of Law, Universitas Padjadjaran, Bandung, Indonesia.
  • Zainal Muttaqin Faculty of Law, Universitas Padjadjaran, Bandung, Indonesia.
  • Mei Susanto Faculty of Law, Universitas Padjadjaran, Bandung, Indonesia.
PDF
Published 23-09-2026
Pages 42-59
Section Articles
Statistics 105 views   28 downloads

Abstract

Recent incidents involving unsafe drugs and food products in Indonesia highlight persistent challenges in regulatory oversight. Although the Food and Drug Supervisory Agency (BPOM) is the primary authority for public health protection, institutional overlap and legal limitations constrain its supervisory effectiveness. This study examines the legal framework governing BPOM’s drug and food supervision and evaluates its institutional position within Indonesia’s constitutional system to identify necessary legal reforms. Unlike previous studies focusing mainly on regulatory implementation, this research analyzes BPOM’s authority from institutional and constitutional perspectives and proposes a reconstruction of its legal framework. A socio-legal approach was employed using statutory, conceptual, historical, and case approaches. Primary data were obtained through interviews with legal experts and practitioners, while secondary data comprised legislation, legal literature, and relevant judicial and policy documents. The findings show that fragmented institutional arrangements and overlapping governmental authority weaken BPOM’s supervisory effectiveness. Existing legislation also provides insufficient support for institutional independence, particularly following the discontinuation of the Draft Law on Drug and Food Supervision. This study proposes reconstructing BPOM’s legal and institutional framework to strengthen regulatory certainty, institutional independence, and public health protection.

    Keywords

  • food and drug supervisory agency (BPOM)
  • legal framework
  • supervision

References

  1. Akbar, Sahda Saraswati, et al. “Legal Liability of Skincare Owners Related to Overclaims on Beauty Products.” Forschungsforum Law Journal 2, no. 1 (2025): 82–88. https://doi.org/10.35586/flj.v2i1.9889.
  2. Asshiddiqie, Jimly. Disputes of Authority Between State Institutions. 1st ed. Jakarta: Constitution Press, 2005.
  3. ———. Introduction to Constitutional Law. Jakarta: Secretariat General and Clerk of the Constitutional Court of the Republic of Indonesia, 2006.
  4. ———. The Development and Consolidation of the State Post-Reform. 2nd ed. Jakarta: Secretariat General and Clerkship of the Constitutional Court of the Republic of Indonesia, 2006.
  5. Barnett, Hilaire. Constitutional and Administrative Law. 4th ed. London: Great Britain, 2002.
  6. CNBC Indonesia. “Many Skincare Overclaim Cases, Here's How to Choose Maklon to Be Safe.” February 6, 2025. https://www.cnbcindonesia.com/lifestyle/20250206175354-33-608594/ramai-kasus-overclaim-skincare-begini-cara-pilih-maklon-agar-aman.
  7. Council of Europe, Project Group on Administrative Law. A Handbook: The Administration and You: Principles of Administrative Law Concerning the Relations between Administrative Authorities and Private Persons. Council of Europe, 1996.
  8. DPD RI. “Committee III DPD RI Working Together with the Minister of Health and BPOM to Discuss the POM Bill.” July 2, 2024. https://www.dpd.go.id/daftar-berita/komite-iii-dpd-ri-rakerbersama-menkes-dan-bpom-bahas-ruu-pom.
  9. Eprilia, Farina Firda. “Interview with Ardini Raksanagara.” Interview with Public Health Science Expert, Faculty of Medicine, Padjadjaran University. Bandung, May 5, 2025.
  10. ———. “Interview with Indra Perwira.” Interview with Constitutional Law Expert, Faculty of Law, Padjadjaran University. Bandung, April 22, 2025.
  11. Fahreza, Afrilian Rizki, and Evi Kongres. “Supervision by the Ministry of Health and BPOM on the Circulation of Children's Syrup Drugs Causing Acute Kidney Failure.” Magna Opus Law Journal 6, no. 2 (June 2023): 105-108.
  12. Firmansyah, Decky. “Three Strong Reasons for the Need to Strengthen the Functions and Authority of the POM Agency.” Pharmaceutical Magazine 3 (2016): 1-4.
  13. Gondokusumo, Marisca, and Nabbilah Amir. “The Role of Government Supervision and the Food and Drug Supervisory Agency (BPOM) in the Circulation of Counterfeit Drugs in the State of Indonesia (Reviewed from Law Number 36 of 2009 and Regulation of the Head of the Food and Drug Management Agency).” Legal Perspective 21, no. 2 (November 17, 2021): 275. https://doi.org/10.30649/ph.v21i2.16.
  14. Hukum Online. “Legal Experts to Professors Urge the Ratification of the POM Bill.” March 6, 2023. https://www.hukumonline.com/berita/a/pakar-hukum-hingga-guru-besar-desak-pengesahan-ruu-pom-lt6405bc41666ad/
  15. ———. “Minister of Health: The Material of the POM Bill Has Been Comprehensively Regulated by a Number of Laws and Implementing Regulations.” July 3, 2024. https://www.hukumonline.com/berita/a/menteri-kesehatan--materi-ruu-pom-sudah-komprehensif-diatur-sejumlah-uu-dan-peraturan-pelaksana-lt6684b9362ddba/
  16. ———. “PPNS Authority Overlaps with Police.” February 21, 2007. https://www.hukumonline.com/berita/a/kewenangan-ppns-tumpang-tindih-dengan-polri-hol16248/
  17. Kemalasari, Yuliana, et al. “The Effectiveness of BPOM RI Supervision on the Circulation of Fever, Flu and Cough Drugs That Cause Death from Acute Kidney Failure in Children.”
  18. Kompas. “Police Arrest Manufacturers of Hundreds of Thousands of Counterfeit and Illegal Drugs.” January 27, 2023. https://www.kompas.id/baca/metro/2023/01/27/sejumlah-430000-butir-obat-obatan-ilegal-telah-beredar-selama-satu-tahun.
  19. Kompas Nasional. “Cases of Acute Kidney Failure, Syrup Raw Materials Management, and the Authority of BPOM.” December 11, 2022. https://nasional.kompas.com/read/2022/11/12/06030091/kasus-gagal-ginjal-akut-oplosan-bahan-baku-obat-sirup-dan-kewenangan-bpom? page=all.
  20. Kurniasanti, and Joko Setiyono. “The Urgency of Regulating Supervision and Law Enforcement by BPOM Against Illegal Drug and Food Trafficking.” Yuriska: Journal of Law 12, no. 2 (June 2022): 73–75. https://doi.org/10.24903/yrs.v12i2.884.
  21. Made Nurmawati et al. State Institutional Law. Denpasar: Faculty of Law, UNUD, 2017.
  22. Marbun, SF. Administrative Justice and Administrative Efforts in Indonesia. Liberty, 1997.
  23. Muhaimin. Legal Research Methods. 1st ed. Mataram: Mataram University Press, 2020.
  24. Mustafa, Umami Allan, et al. “Civil Liability of the Indonesian Food and Drug Supervisory Agency (BPOM) in the Circulation of Drugs Causing Acute Kidney Failure in Children.” Journal of Notary Treatise 4, no. 1 (2023): 377. https://doi.org/10.29303/risalahkenotariatan.v4i1.111.
  25. Ngabito, Rafyanka Ivana Putri. “Analysis of Legal Liability for the Distribution of Skincare Products Proven to Be Overclaimed.” Law, Development & Justice Review 7, no. 3 (2024): 284–301. https://doi.org/10.14710/ldjr.7.2024.284-301.
  26. Pangaribuan, Refo Rivaldo Fransiscus, et al. “Sharing of Power in the System of Government in Indonesia.” Lex Administratum 11, no. 5 (2023): 7–9.
  27. Prabowo, David Eko, and Dede Kurniawan. “Regulation of Supervision of the Food and Drug Supervisory Agency (BPOM) in Consumer Protection.” Journal of Projudice 2, no. 2 (2021): 7.
  28. Prabowo, Edi. Law and Public Policy. YPAPI, 2004.
  29. Ridwan, Juniarso. State Administration Law and Public Service Policy. Nuansa Cendekia, 2009.
  30. Salundik. “Law Enforcement by the Food and Drug Control Agency for Drugs Containing Ethylene Glycol.” Journal of Law Tambun Bungai Palangka Raya 7, no. 2 (2022): 198-199.
  31. Siregar, Dahris. “Legal Assessment of Default in Treaty Law from the Perspective of Contractual Freedom on the Protection of the Parties’ Rights.” Rechtenstudent 7, no. 2 (2026): 103–104.
  32. Soemantri, Taufik Sri. “State Institutions and State Auxiliary Bodies in the Constitutional System According to the 1945 Constitution.” National Dialogue Forum in Legal and Non-Legal Fields, BPHN Ministry of Law and Human Rights of the Republic of Indonesia, June 26–29, 2007.
  33. Soemitro, Ronny Hanitidjo. Legal Research Methodology and Jurimetry. Jakarta: Ghalia Indonesia, 1990.
  34. Siregar, Dahris. “Legal Assessment of Default in Treaty Law from the Perspective of Contractual Freedom on the Protection of the Parties’ Rights.” Rechtenstudent 7, no. 2 (2026): 103–104.
  35. Usman, Arief Handoko. “Optimizing Drug and Food Circulation Supervision in the Context of Public Health Protection.” Juristic 4, no. 3 (December 2023): 343–344.
  36. William, Dicky. “Counterfeit Drug Circulation Reviewed from Health Law and Information Law and Electronic Transactions.” Bandung Conference Series: Law Study 2, no. 1 (2022): 288–289.
  37. Wismaya, Indira Ratna, and Husni Syam. “Legal Liability of BPOM and Business Actors for the Circulation of Toxins in Paracetamol Syrup Drugs Reviewed from the Regulation of the Food and Drug Control Agency.” Bandung Conference Series: Law Studies (2024): 573–574.
Issue Vol. 11 No. 1 (2026): Jurnal Bina Mulia Hukum Volume 11 Number 1 September 2026

License

Copyright (c) 2026 Farina Firda Eprilia, Zainal Muttaqin, Mei Susanto

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.